Article: Guidance on Clause 4.2 of ISO 9001:2008

Guidance on Clause 4.2 of ISO 9001:2008

The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.

a) Documented statements of a quality policy and objectives:

− Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3. Note Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).

− Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.

b) Quality Manual:

− Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS

− A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.

− Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.

− The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.

Article: ISO 9001:2008 Documentation Requirements

ISO 9001:2008 Documentation Requirements

ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”

Clause 4.2.1 General explains that the quality management system documentation shall include:

a) documented statements of a quality policy and quality objectives;

b) a quality manual

c) documented procedures required by this International Standard

d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and

e) records required by this International Standard;

Requirements of ISO 9001:2008 - What is a document

Article: Requirements of ISO 9001:2008 - What is a document

What is a “document”? - Definitions and references

The following are some of the main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS;

a) Communication of Information

- as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.

b) Evidence of conformity

- provision of evidence that what was planned, has actually been done.

c) Knowledge sharing

- to disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.